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StruCtuRal And FuncTional Brain Alterations by Conventional Spinal Cord Stimulation And High DensitY Stimulation (SCRATCHY)

Primary Purpose

Failed Back Surgery Syndrome

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
fMRI
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring spinal cord stimulation, resting state functional magnetic resonance, voxel-based magnetic resonance morphometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is at least 18 years old.
  • Subject is able and willing to comply with the follow-up schedule and protocol
  • Diagnosis of FBSS with predominant leg pain (VAS) > 5) and non-dominant back pain.
  • Cognitive and language functioning enabling coherent communication between the examiner and the subject;
  • Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy
  • Stable neurologic function in the past 30 days
  • In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
  • Subject is able to provide written informed consent
  • Subject speaks Dutch or French.

Exclusion Criteria:

  • Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial
  • Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
  • Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator, deep brain stimulator or intrathecal drug pump
  • Subject is unable to operate the device or has no relative available.
  • Subjects with indwelling devices that may pose an increased risk of infection
  • Subject currently has an active infection
  • Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
  • Subject has participated in another clinical investigation within 30 days
  • Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
  • Subject has been diagnosed with cancer in the past 2 years
  • Life expectancy < 6 months
  • Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement
  • Existing extreme fear for entering MRI
  • General contraindication for MRI (pacemaker, etc…)
  • Age male/female patient <18 years

Sites / Locations

  • UZ Brussel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

spinal cord stimulation

Arm Description

The Vectris® SureScan® MRI lead will be connected to a RestoreSensor® SureScan® MRI neurostimulator.

Outcomes

Primary Outcome Measures

Grey Mater Volume assessed by Voxel-based morphometry analysis (based on MRI images)
Functional connectivity analysis using in-house developed software (based on MRI images)

Secondary Outcome Measures

Visual Analogue Scale (VAS) pain diary
Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).
Subjective sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI)
Pain catastrophizing is assessed by the Pain Catastrophizing Scale (PCS)
Likert-scale in order to evaluate the satisfaction grade of the patient.

Full Information

First Posted
December 24, 2015
Last Updated
April 16, 2019
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02650349
Brief Title
StruCtuRal And FuncTional Brain Alterations by Conventional Spinal Cord Stimulation And High DensitY Stimulation
Acronym
SCRATCHY
Official Title
StruCtuRal And FuncTional Brain Alterations by Conventional Spinal Cord Stimulation And High DensitY Stimulation: a Combined Voxel-based Morphometry and Resting State Functional Connectivity Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is an interventional prospective observatory single center trial, investigating the supraspinal effects of long term conventional SCS (60 Hz) and paresthesia-free high density SCS in failed back surgery syndrome (FBSS) patients with back and leg pain completed with resting state functional magnetic resonance (rs fMRI) and voxel-based magnetic resonance morphometry (VBM).
Detailed Description
When patient meets all inclusion criteria and no exclusion criteria, a neuroimaging protocol will be obtained at baseline, prior to trial implantation of SCS. At trial implantation a Vectris® SureScan® MRI 1x8 lead will be implanted, targeted by intraoperative mapping. This lead will be connected to a temporary extension cable and ENS. Normal trial period will be respected based on the reimbursement rules in Belgium (4 weeks). When the patient is eligible for implantation of the definitive SCS system (more than 50% pain reduction and/or more than 50% reduction in pain medication), patient will undergo surgery for definitive implantation. Then the Vectris® SureScan® MRI lead will be connected to a RestoreSensor® SureScan® MRI neurostimulator. After stabilisation of the stimulation parameters at least for more than 1 month, the second session of neuroimaging will occur (T1) with the RestoreSensor® SureScan® MRI neurostimulator in MRI mode. Minimal one month later ( 2 months after implantation of definitive SCS system) the patient will undergo the last session of neuroimaging (T2) with the stimulator in MRI mode. During that period prior to the MR-session, a new protocol will occur with paresthesia free high density SCS. The MRI protocol will occur after stabilisation of the stimulation parameters at least for more than 1 month. During the whole period, patients will fill in a VAS diary (back and leg pain separately) and at time of neuroimaging T1 and T2 a Likert-scale in order to evaluate the satisfaction grade of the patient. Additionally, patients will also wear during the whole period an Actiwatch, measuring sleep patterns and filling in questionnaires at B, T1 and T2 (Pittsburgh Sleep Quality Index (PSQI) and Holland Sleep Disorders Questionnaire (HSDQ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome
Keywords
spinal cord stimulation, resting state functional magnetic resonance, voxel-based magnetic resonance morphometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
spinal cord stimulation
Arm Type
Experimental
Arm Description
The Vectris® SureScan® MRI lead will be connected to a RestoreSensor® SureScan® MRI neurostimulator.
Intervention Type
Other
Intervention Name(s)
fMRI
Primary Outcome Measure Information:
Title
Grey Mater Volume assessed by Voxel-based morphometry analysis (based on MRI images)
Time Frame
The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).
Title
Functional connectivity analysis using in-house developed software (based on MRI images)
Time Frame
The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) pain diary
Time Frame
Three times every day (morning, afternoon and evening), starting 1 week before baseline measurements up to 2 months until study completion.
Title
Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).
Time Frame
The difference between 7 days at baseline before implantation and 7 days before T1 ( 1 month after definitive implantation) and 7 days before T2 ( 2 months after definitive implantation).
Title
Subjective sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).
Title
Pain catastrophizing is assessed by the Pain Catastrophizing Scale (PCS)
Time Frame
The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).
Title
Likert-scale in order to evaluate the satisfaction grade of the patient.
Time Frame
The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is at least 18 years old. Subject is able and willing to comply with the follow-up schedule and protocol Diagnosis of FBSS with predominant leg pain (VAS) > 5) and non-dominant back pain. Cognitive and language functioning enabling coherent communication between the examiner and the subject; Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy Stable neurologic function in the past 30 days In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device Subject is able to provide written informed consent Subject speaks Dutch or French. Exclusion Criteria: Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial Subject has had radiofrequency treatment of an intended target DRG within the past 3 months Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator, deep brain stimulator or intrathecal drug pump Subject is unable to operate the device or has no relative available. Subjects with indwelling devices that may pose an increased risk of infection Subject currently has an active infection Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device Subject has participated in another clinical investigation within 30 days Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation Subject has been diagnosed with cancer in the past 2 years Life expectancy < 6 months Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement Existing extreme fear for entering MRI General contraindication for MRI (pacemaker, etc…) Age male/female patient <18 years
Facility Information:
Facility Name
UZ Brussel
City
Brussels
State/Province
Vlaams Brabant
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
15770488
Citation
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Results Reference
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PubMed Identifier
17977762
Citation
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Citation
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StruCtuRal And FuncTional Brain Alterations by Conventional Spinal Cord Stimulation And High DensitY Stimulation

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